Staged deployment devices and method for transcatheter heart valve delivery

ABSTRACT

A delivery device for a collapsible heart valve includes an operating handle and a catheter assembly. The operating handle includes a frame defining a movement space therein, a carriage assembly moveable in a longitudinal direction within the movement space, and a coupler having locked and unlocked conditions, the coupler being operatively connected to the carriage assembly for movement therewith. The catheter assembly includes a shaft around which a valve-receiving compartment is defined, the shaft being operatively connected to one of the frame or the carriage assembly, and a distal sheath operatively connected to the carriage assembly for movement therewith between a closed condition adapted to maintain the valve in the compartment and an open condition adapted to fully deploy the valve.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of U.S. Provisional PatentApplication Ser. No. 61/384,032, filed Sep. 17, 2010, entitled “StagedDeployment Devices and Methods for Transcatheter Heart Valve Delivery,”the disclosure of which is hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention is related to prosthetic heart valve replacement,and more particularly to devices, systems, and methods for transcatheterdelivery of collapsible prosthetic heart valves.

Prosthetic heart valves that are collapsible to a relatively smallcircumferential size can be delivered into a patient less invasivelythan valves that are not collapsible. For example, a collapsible valvemay be delivered into a patient via a tube-like delivery apparatus suchas a catheter, a trocar, a laparoscopic instrument, or the like. Thiscollapsibility can avoid the need for a more invasive procedure such asfull open-chest, open-heart surgery.

Collapsible prosthetic heart valves typically take the form of a valvestructure mounted on a stent. There are two types of stents on which thevalve structures are ordinarily mounted: a self-expanding stent and aballoon-expandable stent. To place such valves into a delivery apparatusand ultimately into a patient, the valve must first be collapsed orcrimped to reduce its circumferential size.

When a collapsed prosthetic valve has reached the desired implant sitein the patient (e.g., at or near the annulus of the patient's heartvalve that is to be replaced by the prosthetic valve), the prostheticvalve can be deployed or released from the delivery apparatus andre-expanded to full operating size. For balloon-expandable valves, thisgenerally involves releasing the entire valve, assuring its properlocation, and then expanding a balloon positioned within the valvestent. For self-expanding valves, on the other hand, the stentautomatically expands as the sheath covering the valve is withdrawn.

In conventional delivery systems for self-expanding aortic valves, forexample, after the delivery system has been positioned for deployment,the annulus end of the valve is typically unsheathed and expanded first,while the aortic end of the valve remains sheathed. Once the annulus endof the valve has expanded, it may be determined that the valve needs tobe repositioned in the patient's aortic annulus. To accomplish this, auser (such as a surgeon or an interventional cardiologist) typicallyresheathes the annulus end of the valve, so that the valve can berepositioned while in a collapsed state. After the valve has beenrepositioned, the user can again release the valve.

Once a self-expanding valve has been fully deployed, it expands to adiameter larger than that of the sheath that previously contained thevalve in the collapsed condition, making resheathing impossible, ordifficult at best. In order for the user to be able to resheathe apartially-deployed valve, a portion of the valve must still be collapsedinside of the sheath.

Despite the various improvements that have been made to the collapsibleprosthetic heart valve delivery process, conventional delivery devices,systems, and methods suffer from some shortcomings. For example, inconventional delivery devices for self-expanding valves, it is difficultto control how much of the valve remains in the sheath during a partialdeployment, and the user may accidentally deploy the valve fully beforeverifying that the annulus end of the valve is in the optimal positionin the patient's valve annulus, thereby taking away the opportunity toresheathe and reposition the valve.

There therefore is a need for further improvements to the devices,systems, and methods for transcatheter delivery of collapsibleprosthetic heart valves, and in particular, self-expanding prostheticheart valves. Among other advantages, the present invention may addressone or more of these needs.

BRIEF SUMMARY OF THE INVENTION

A delivery device for a collapsible prosthetic heart valve and a methodof delivering a collapsible prosthetic heart valve in a patient aredisclosed.

A delivery device for a collapsible prosthetic heart valve includes anoperating handle, including a frame defining a movement space therein, acarriage assembly moveable in a longitudinal direction within themovement space, and a coupler having a locked condition in which thecoupler is connected to the frame in a fixed position, and an unlockedcondition in which the coupler is movable in the longitudinal directionwithin the movement space, the coupler being operatively connected tothe carriage assembly for movement therewith. The delivery device alsoincludes a catheter assembly, including a first shaft around which acompartment is defined, the first shaft being operatively connected toone of the frame or the carriage assembly, the compartment being adaptedto receive the valve in an assembled condition, and a distal sheathoperatively connected to the carriage assembly, the distal sheath beingmoveable between a closed condition adapted to maintain the valve in theassembled condition and an open condition adapted to fully deploy thevalve, wherein movement of the carriage assembly in the longitudinaldirection in the movement space moves the distal sheath between theclosed condition and the open condition.

The coupler may be selectively lockable to the frame in any of aplurality of fixed positions in the longitudinal direction. The couplermay include a releasable pin and the frame may have a plurality of fixednotches, the pin being engageable in one of the notches to lock thecoupler to the frame. The coupler may be selectively lockable to theframe in positions that correspond to positions of the distal sheathbetween the closed condition and the open condition. The operatinghandle may further include a threaded rod extending from the carriageassembly through the coupler, and a deployment actuator threadedlyengaged with the threaded rod and longitudinally constrained relative tothe coupler, such that rotation of the deployment actuator may move thecarriage assembly in the longitudinal direction in the movement space.Rotation of the deployment actuator in a first direction may move thecarriage assembly proximally in the longitudinal direction in themovement space, and rotation of the deployment actuator in a seconddirection opposite the first direction may move the carriage assemblydistally in the longitudinal direction in the movement space.

The delivery device may further include a latch mechanism adapted toreleasably fix the coupler relative to the frame at any of a pluralityof longitudinal positions in the movement space. The operating handlemay further include a resheathing lock having a locked position and anunlocked position, the resheathing lock in the locked position limitingmovement of the carriage assembly in the longitudinal direction to astop position in the movement space, and the resheathing lock in theunlocked position permitting movement of the carriage assembly beyondthe stop position, wherein movement of the carriage assembly to the stopposition may move the distal sheath to a condition between the closedcondition and the open condition so that the valve is not fullydeployed. The frame may include a slot and the resheathing lock mayinclude a retractable pin that is engaged in the slot when theresheathing lock is in the locked position, and a stop member locatedwithin the slot may define the stop position. The stop member may belongitudinally moveable within the slot, such that movement of the stopmember may change the location of the stop position relative to theframe.

The compartment may have a first length and the stop position in themovement space may correspond to a travel distance of the carriageassembly, the travel distance being less than the first length. Thecollapsible prosthetic heart valve may have a second length and thetravel distance may be between about 80% and about 90% of the secondlength. The first shaft may be operatively connected to the frame, thecatheter assembly further including an outer shaft connecting thecarriage assembly to the distal sheath and at least partiallysurrounding the first shaft. The first shaft may be operativelyconnected to the frame, and the operating handle may further include amechanism adapted to move the first shaft proximally relative to theframe. The mechanism may include a threaded rod operatively connected tothe first shaft and extending in the longitudinal direction, and a nutthreadedly engaged with the threaded rod and longitudinally constrainedrelative to the frame.

The first shaft may be operatively connected to the carriage assembly,the catheter assembly further including an outer shaft connecting theframe to the compartment and at least partially surrounding the firstshaft. The first shaft may be operatively connected to the carriageassembly, and the operating handle may further include a mechanismadapted to move the first shaft proximally relative to the carriageassembly. The mechanism may include a threaded rod operatively connectedto the first shaft and extending in the longitudinal direction, and anut threadedly engaged with the threaded rod and longitudinallyconstrained relative to the carriage assembly.

A method of delivering a collapsible prosthetic heart valve in a patientincludes providing a delivery device having a catheter assembly and anoperating handle, the catheter assembly including a compartment adaptedto receive the valve in an assembled condition, the operating handleincluding a frame defining a movement space therein, a carriage assemblymoveable in a longitudinal direction within the movement space, and acoupler operatively connected to the carriage assembly for movementtherewith. The method also includes loading the valve into thecompartment of the catheter assembly, the compartment and the valvebeing covered by a distal sheath of the catheter assembly, inserting thecatheter assembly into the patient, positioning the valve at a targetlocation within the patient, partially deploying the valve by moving thecarriage assembly of the operating handle in a first longitudinaldirection along a first portion of the movement space, and fullydeploying the valve by translating the coupler of the operating handleto continue movement of the carriage assembly in the first longitudinaldirection along a second portion of the movement space.

The operating handle may further include a threaded rod extending fromthe carriage assembly through the coupler, and a deployment actuatorthreadedly engaged with the threaded rod and longitudinally constrainedrelative to the coupler, and the partially deploying step may includerotating the deployment actuator. The operating handle may furtherinclude a resheathing lock having a locked position and an unlockedposition, the resheathing lock in the locked position limiting movementof the carriage assembly in the longitudinal direction to a stoplocation in the movement space, the resheathing lock in the unlockedposition permitting movement of the carriage assembly beyond the stoplocation. The method may further include adjusting a position of theresheathing lock in the longitudinal direction to set the stop locationin the movement space. The method may further include resheathing thevalve by moving the carriage assembly in a second longitudinal directionopposite the first longitudinal direction.

The catheter assembly may further include a first shaft around which thecompartment is defined and an outer shaft connecting the carriageassembly to the distal sheath and at least partially surrounding thefirst shaft, the first shaft may be operatively connected to the frame,the distal sheath may be operatively connected to the carriage assembly,and the steps of partially deploying the valve and fully deploying thevalve may each include moving the outer shaft proximally relative to theframe. The catheter assembly may further include a first shaft aroundwhich the compartment is defined, the first shaft may be operativelyconnected to the frame, the distal sheath may be operatively connectedto the carriage assembly, and the resheathing step may include movingthe first shaft proximally relative to the frame and the distal sheath.

The operating handle may further include a threaded rod operativelyconnected to the first shaft and extending in the longitudinaldirection, and a nut threadedly engaged with the threaded rod andlongitudinally constrained relative to the frame, and the step of movingthe first shaft may include rotating the nut about the threaded rod. Theoperating handle may further include a resheathing lock having a lockedposition and an unlocked position, the resheathing lock in the lockedposition limiting movement of the carriage assembly in the longitudinaldirection to a stop location in the movement space, the resheathing lockin the unlocked position permitting movement of the carriage assemblybeyond the stop location, and the step of moving the first shaft may beperformed with the resheathing lock in the locked position.

The catheter assembly may further include a first shaft around which thecompartment is defined and an outer shaft connecting the frame to thecompartment and at least partially surrounding the first shaft, thefirst shaft and the distal sheath may be operatively connected to thecarriage assembly, and the steps of partially deploying the valve andfully deploying the valve may each include moving the first shaftdistally relative to the frame. The catheter assembly may furtherinclude a first shaft around which the compartment is defined, the firstshaft and the distal sheath may be operatively connected to the carriageassembly, and the resheathing step may include moving the first shaftproximally relative to the carriage assembly.

The operating handle may further include a threaded rod operativelyconnected to the first shaft and extending in the longitudinaldirection, and a nut threadedly engaged with the threaded rod andlongitudinally constrained relative to the carriage assembly, and thestep of moving the first shaft may include rotating the nut about thethreaded rod. The operating handle may further include a resheathinglock having a locked position and an unlocked position, the resheathinglock in the locked position limiting movement of the carriage assemblyin the longitudinal direction to a stop location in the movement space,the resheathing lock in the unlocked position permitting movement of thecarriage assembly beyond the stop location, and the step of moving thefirst shaft may be performed with the resheathing lock in the lockedposition. The target location within the patient may be the nativeaortic annulus of the patient. The distal sheath of the delivery devicemay be inserted through a femoral artery of the patient. The distalsheath of the delivery device may be inserted through the apex of theheart of the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present invention will now be described withreference to the appended drawings. It is appreciated that thesedrawings depict only some embodiments of the invention and are thereforenot to be considered limiting of its scope.

FIG. 1 is a perspective view of an operating handle for a transfemoraldelivery device for a collapsible prosthetic heart valve, shown with aside elevation of the distal portion of a transfemoral catheterassembly;

FIG. 2 is an enlarged bottom plan view of a portion of the handle ofFIG. 1;

FIG. 3 is an enlarged bottom plan view of another portion of the handleof FIG. 1, with portions removed to illustrate the interior thereof; and

FIG. 4 is a bottom plan view of an operating handle for a transapicaldelivery device for a collapsible prosthetic heart valve, shown with aside elevation of the distal portion of a transapical catheter assembly.

DETAILED DESCRIPTION

As used herein, the terms “proximal” and “distal” are to be taken asrelative to a user using the disclosed delivery devices. “Proximal” isto be understood as relatively close to the user and “distal” is to beunderstood as relatively farther away from the user.

Referring now to FIGS. 1 and 2 to illustrate the structure and functionof the present invention, an exemplary transfemoral delivery device 10for a collapsible prosthetic heart valve (or other types ofself-expanding collapsible stents) has a catheter assembly 16 fordelivering the heart valve to and deploying the heart valve at a targetlocation, and an operating handle 20 for controlling deployment of thevalve from the catheter assembly. The delivery device 10 extends from aproximal end 12 to a distal tip 14. The catheter assembly 16 is adaptedto receive a collapsible prosthetic heart valve (not shown) in acompartment 23 defined around an inner shaft 26 and covered by a distalsheath 24.

The inner shaft 26 extends through the operating handle 20 to the distaltip 14 of the delivery device, and includes a retainer 25 affixedthereto at a spaced distance from distal tip 14 and adapted to hold acollapsible prosthetic valve in the compartment 23.

The distal sheath 24 surrounds the inner shaft 26 and is slidablerelative to the inner shaft such that it can selectively cover oruncover the compartment 23. The distal sheath 24 is affixed at itsproximal end to an outer shaft 22, the proximal end of which isconnected to the operating handle 20 in a manner to be described. Thedistal end 27 of the distal sheath 24 abuts the distal tip 14 when thedistal sheath is fully covering the compartment 23, and is spaced apartfrom the distal tip 14 when the compartment 23 is at least partiallyuncovered.

The operating handle 20 is adapted to control deployment of a prostheticvalve located in the compartment 23 by permitting a user to selectivelyslide the outer shaft 22 proximally or distally relative to the innershaft 26, thereby respectively uncovering or covering the compartmentwith the distal sheath 24. The proximal end of the inner shaft 26 isoperatively coupled to an outer frame 30 of the operating handle 20 (thelongitudinal position of the inner shaft relative to the frame can beadjusted, as described below), and the proximal end of the outer shaft22 is affixed to a carriage assembly 40 of the operating handle that isslidable along a longitudinal axis of the frame, such that a user canselectively slide the outer shaft relative to the inner shaft by slidingthe carriage assembly relative to the frame.

A hemostasis valve 28 includes an internal gasket adapted to create aseal between the inner shaft 26 and the proximal end of the outer shaft22. A gasket adjustment wheel 42 in the carriage assembly 40 is adaptedto adjust the strength of this seal. For example, the gasket inside thehemostasis valve 28 may be in the shape of an O-ring located around theinner shaft 26, or between the O-ring and the inner surface of the outershaft 22. When the strength of the seal is insufficient, there may be agap between the O-ring and the outer surface of the inner shaft 26,and/or between the O-ring and the inner surface of the outer shaft 22.To eliminate this gap, a user can turn the gasket adjustment wheel 42 toplace a compressive force on the O-ring in the longitudinal direction ofthe inner shaft 26, thereby compressing the O-ring longitudinally andexpanding the O-ring radially. The radially-expanded O-ring can fill anygap between the O-ring and the outer surface of the inner shaft 26 orthe inner surface of the outer shaft 22, thereby creating a liquid-proofseal therebetween.

The frame 30 includes a pair of side rails 31 joined at the proximal end12 by a proximal end member 32 and joined at the distal end by a distalend member 33. Collectively, the side rails 31, the end member 32, andthe end member 33 define an elongated space 34 in the frame 30 in whichthe carriage assembly 40 may travel. The elongated space 34 preferablypermits the carriage assembly 40 to travel a distance that is at leastas long as the anticipated length of the prosthetic valve to bedelivered (e.g., at least about 50 mm), such that the distal sheath 24can be fully retracted from around the prosthetic valve. An enlargedbore 35 in the end member 33 is sized to freely and slidingly receive athreaded rod 36 extending from the distal end of the carriage assembly40, as described below. The enlarged bore 35 has a smooth interiorsurface and an inner diameter slightly larger than the outer diameter ofthe threaded rod 36 (a longitudinal cross-section of the threaded rodpositioned inside of the enlarged bore is shown in FIG. 2).

The carriage assembly 40 includes a main body 41 and the threaded rod 36extending distally therefrom along the longitudinal axis of the frame30. The threaded rod 36 preferably is longer than the anticipatedmaximum travel distance of the carriage assembly 40 within the elongatedspace 34 (e.g., at least about 50 mm), such that the threaded rod 36does not fully withdraw from the enlarged bore 35 during deployment ofthe prosthetic valve.

A coupler 60 includes a top member 61 and a bottom member 62 joined toone another so as to define a pair of channels 70 extendinglongitudinally therebetween, the channels being sized and shaped toslidingly receive the side rails 31 of the frame 30 therethrough. Thelateral sides 66 of the coupler 60 may include vertically-extendingridges 67 to facilitate grasping and moving of the coupler. The topmember 61 and the bottom member 62 further define a central bore 71extending longitudinally therebetween and sized to freely and slidinglyreceive the threaded rod 36 therethrough, as well as a pocket 72extending vertically therethrough for receiving a deployment actuator 21in threaded engagement with the threaded rod. The pocket 72 is sized andshaped to receive the deployment actuator 21 with minimal clearance,such that the deployment actuator remains substantially fixed relativeto the coupler 60 as it is rotated on the threaded rod 36. That is,rotation of the deployment actuator 21 in one direction (eitherclockwise or counterclockwise depending on the orientation of thethreads on the threaded rod 36) causes the threaded rod 36 to moveproximally within the central bore 71, at the same time pushing thecarriage assembly 40 proximally through the elongated space 34.Similarly, rotation of the deployment actuator 21 in the oppositedirection causes the threaded rod 36 to move distally within the centralbore 71, at the same time pulling the carriage assembly distally throughthe elongated space 34.

The coupler 60 may include a pair of locking members 80 positioned onopposite lateral sides 66 thereof. Each locking member 80 may beslidably received in a socket 73 extending laterally inward from thelateral sides 66 of the coupler 60 to an end surface 68. The lockingmembers 80 are biased laterally outward from the lateral sides 66 by aspring 81 positioned between the inner end of the locking member and theend surface 68 of the socket 73. A pin 83 extending upward from eachlocking member 80 is sized to be selectively engaged in one of aplurality of notches 37 formed in an inner surface 39 of each side rail31. The engagement of the pins 83 in the notches 37 locks the coupler 60and the deployment actuator 21 to the frame 30, so as to permit rotationof the deployment actuator in both directions without translation ofsame within the space 34. Simultaneously depressing both locking members80 against the bias of the springs 81 causes the pins 83 to move out ofengagement with the notches 37, thereby freeing the coupler 60 and thedeployment actuator 21 to move longitudinally relative to the frame 30.

The capability of the deployment actuator 21 to become longitudinallyconstrained relative to the frame 30 may provide a user with the abilityto carefully control movement of the carriage assembly 40 bothproximally within the space 34 during a valve deployment operation, anddistally within the space 34 during a resheathing operation, asdescribed more fully below. The capability of the deployment actuator 21to freely move longitudinally relative to the frame 30 enables grossmovement of the carriage assembly 40 proximally or distally within thespace 34 without the mechanical advantage provided by the deploymentactuator. Such movement is not easily controllable, but rather issubject to the “touch and feel” of the user.

The carriage assembly 40 may include a resheathing lock adapted to limitthe longitudinal movement of the carriage assembly within the outerframe 30, thereby preventing a user from completing the deployment of aprosthetic valve when unintended. The resheathing lock includes acontrol member 50 that is longitudinally slidable in a slot 46 between adistal position (shown in FIG. 1) and a proximal position (not shown).

The control member 50 is operatively coupled to a pin 51 that projectslaterally through an aperture 48 in the main body 41 of the carriageassembly 40. With the carriage assembly 40 in its initial position(shown in FIG. 1), the aperture 48 may be aligned with the distal end38′ of a longitudinally extending slot 38 in the side rail 31 of theframe 30, or the aperture may be aligned with another location withinthe slot (e.g., in FIG. 2, the aperture is aligned with a location nearthe center of the slot). When the control member 50 is in its distalmostposition (shown in FIG. 1), the pin 51 will extend through the aperture48 and into the slot 38. Such condition will enable the carriageassembly 40 to move longitudinally within the frame 30 between aninitial position at which the distal end of the carriage assemblycontacts the coupler 60 and a position at which the pin 51 contacts astop member 52 that is longitudinally adjustable within the slot, asdiscussed below. In the initial position, the pin 51 may contact thedistal end 38′ of the slot 38 or may be spaced therefrom by apredetermined distance. Movement of the control member 50 proximallycauses the pin 51 to move laterally inward until the pin is no longerengaged in the slot 38. This action thus frees the carriage assembly 40for further proximal movement relative to the frame 30, therebypermitting full deployment of a prosthetic valve from the compartment23.

While essentially any mechanism usable for controlling lateralretraction of a pin can be used to operatively couple the control member50 to the pin 51 described herein, example cam-based mechanisms that canbe employed are discussed in greater detail in co-pending U.S. PatentApplication No. 61/376,425, filed on Aug. 24, 2010, the disclosure ofwhich is hereby incorporated by reference herein.

An initial distance D1 that the carriage assembly 40 can travel beforebeing limited by the stop member 52 may be adjustable. That is, the stopmember 52 may be fixed to the side rail 31 of the frame 30 by screws 53extending through a longitudinally extending slot 54 in the side rail.By loosening the screws 53, the stop member 52 may be slid proximally ordistally within slot 38 to a desired position, at which the screws maybe retightened to lock the stop member in place.

The initial distance D1 that the carriage assembly 40 can travel beforebeing limited by the stop member 52 may depend on the structure of theparticular prosthetic valve to be deployed. Preferably, the initialtravel distance D1 of the carriage assembly 40 is about 3 mm to about 5mm less than the crimped valve length. Alternatively, the initial traveldistance D1 of the carriage assembly 40 may be about 40 mm to about 45mm, which is about 80% to about 90% of the length of an exemplary 50 mmvalve. In other arrangements, the initial distance D1 that the carriageassembly 40 can travel can be determined as a percentage of the lengthof the prosthetic valve and/or the compartment 23, including, forexample, 50%, 60%, 70%, 75%, 85%, or 95%.

Referring now to FIG. 3, the proximal end member 32 of the frame 30 hasan inside frame wall 90 that defines the proximal end of the elongatedspace 34, and an outside frame wall 91 that defines the proximal end 12of the delivery device 10. The proximal end member 32 includes a centralbore 92 extending longitudinally therethrough between the inside framewall 90 and the outside frame wall 91 and sized to freely and slidinglyreceive a threaded rod 94 therethrough. A pocket 93 extends verticallythrough the proximal end member 32 for receiving a shaft adjustment nut99 in threaded engagement with the threaded rod 94. The pocket 93 issized and shaped to receive the shaft adjustment nut 99 with minimalclearance, such that the shaft adjustment nut remains substantiallyfixed relative to the frame 30 as it rotates on the threaded rod 94.Accordingly, rotation of the shaft adjustment nut 99 in one direction(either clockwise or counterclockwise depending on the orientation ofthe threads on the threaded rod 94) causes the threaded rod 94 to moveproximally within the central bore 92, and rotation of the shaftadjustment nut 99 in the opposite direction causes the threaded rod 94to move distally within the central bore 92.

The threaded rod 94 has an interior bore 95 extending longitudinallytherethrough. A distal portion 96 of the bore 95 has an inner diameterequal to or slightly larger than the outer diameter of the inner shaft26. A proximal portion 97 of the bore 95 has an inner diameter equal toor slightly larger than a hub 19 fixed to the proximal end of the innershaft 26. An annular rib 29 extending around the inner shaft 26 may becaptured within an annular groove 98 formed in the distal portion 96 ofthe bore 95 to fix the inner shaft 26 longitudinally to the threaded rod94. As a result, as the threaded rod 94 moves longitudinally uponrotation of the shaft adjustment nut 99, the inner shaft 26 will movelongitudinally along with it.

The operation of the present invention to deploy a prosthetic valve willnow be described. To load the delivery device 10 with a collapsibleprosthetic valve, a user can retract the distal sheath 24 to expose thecompartment 23, place the valve around the inner shaft 26, couple theproximal end of the valve to the retainer 25, compresses or crimp thevalve, and slide the distal sheath 24 over the compartment, which holdsthe valve in a compressed state. In this starting condition, the handle20 will be in an initial state with the carriage assembly 40 at itsdistalmost position within the frame 30, the resheathing lock will be inits locked position to prevent full deployment, and the coupler 60 willbe at its distalmost position within the frame.

To use the operating handle 20 to deploy a prosthetic valve that hasbeen compressed and inserted in the compartment 23 and covered by thedistal sheath 24, a user may rotate the deployment actuator 21, causingthe carriage assembly 40 to slide proximally within the elongated space34 in the frame 30. Because the distal sheath 24 is affixed to the outershaft 22, which in turn is affixed to the carriage assembly 40, andbecause the inner shaft 26 is fixed to the frame 30 (although thelongitudinal position of the inner shaft relative to the frame can beadjusted, as described above), sliding the carriage assembly proximallyrelative to the frame will retract the distal sheath proximally from thecompartment 23, thereby exposing and initiating deployment of the valvelocated therein.

It will be appreciated that the user may initiate the deployment processwithout use of the deployment actuator 21 by simply squeezing thelocking members 80 inwardly towards one another to release the coupler60, and simultaneously pulling the coupler proximally within the frame30. As the coupler 60 is pulled proximally within the frame 30, thelinking of the coupler to the carriage assembly 40 through the threadedrod 36 and the deployment actuator 21 results in a concomitant proximalmovement of the carriage assembly. Such action requires significantpulling force in order to overcome the frictional forces acting on theouter shaft 22 and the distal sheath 24. For that reason, the use of thedeployment actuator 21 to begin retracting the distal sheath 24 ispreferred since such use provides the user with a mechanical advantageto overcome the aforementioned frictional forces, thereby providing theuser with much greater control of the deployment process.

After the distal sheath 24 has been partially retracted from thecompartment 23, the portion of the prosthetic valve that includes tissuemay be fully exposed, so that the frictional forces acting between thevalve and the distal sheath are greatly reduced. At this point, it ispreferred that the user continue the deployment process without use ofthe deployment actuator 21 by squeezing the locking members 80 inwardlytowards one another while pulling the coupler 60 and the carriageassembly 40 proximally within the frame 30. Although the user will nothave a mechanical advantage without using the deployment actuator 21 tomove the carriage assembly 40 proximally, continuing the deploymentprocess while squeezing the locking members 80 may allow such process tobe completed more quickly.

In any event, since the resheathing lock is in the locked position,movement of the carriage assembly 40 proximally may continue only untilthe pin 55 contacts the stop member 52. At this point, the distal sheath24 will not be fully withdrawn from the compartment 23, and theprosthetic valve will not be fully deployed.

When the deployment procedure has reached this juncture, the user canevaluate the position of the valve and determine whether the annulus endof the valve is properly aligned relative to the patient's aorticannulus. If repositioning is desired, the user may resheathe the valveby rotating the deployment actuator 21 in the direction opposite thatused for deployment. Such rotation will cause the threaded rod 36 toprogress distally through the deployment actuator 21 until the carriageassembly 40 has reached the starting condition shown in FIGS. 1 and 2,thereby moving the distal sheath 24 distally over the compartment 23 andthe partially deployed valve and recollapsing the expanded part of thevalve. With the valve resheathed, the user can reposition the deliverydevice 10 and commence the deployment procedure once again.

If, during deployment, the coupler 60 has been moved proximally awayfrom the distal end member 33 of the frame 30, it will be appreciatedthat the user may partially or fully resheathe the valve without use ofthe deployment actuator 21 by simply squeezing the locking members 80inwardly towards one another to release the coupler 60, andsimultaneously pushing the coupler distally within the frame 30. As thecoupler 60 is pushed distally within frame 30, the linking of thecoupler to the carriage assembly results in a concomitant distalmovement of the carriage assembly. Such action requires significantpushing force in order to overcome the frictional forces acting on theouter shaft 22 and the distal sheath 24, as well as the resilient forceswhich expand the stent portion of the valve. For that reason, the use ofthe deployment actuator 21 to replace the distal sheath 24 over thecompartment 23 is preferred since such use provides the user with amechanical advantage to overcome the aforementioned forces.

If, during deployment, the user has partially deployed and thenresheathed the valve, the outer shaft 22 and/or the inner shaft 26 mayhave become temporarily or permanently deformed, such that therespective distal ends thereof may be longitudinally displaced relativeto one another. During resheathing, the aforementioned frictional forceswill tend to longitudinally compress the outer shaft 22 and stretch theinner shaft 26, for example, by a total length distributed between theinner and outer shafts of about 3 mm to about 10 mm. Such permanentdeformation of these components may result in an inability of the distalsheath 24 to completely cover the compartment 23 such that the distalend 27 of the distal sheath may not extend far enough to abut the distaltip 14.

To adjust the relative longitudinal positions of the distal tip 14 andthe distal sheath 24, the user may rotate the shaft adjustment nut 99,causing the threaded rod 94 and the inner shaft 26 affixed thereto toslide proximally relative to the frame 30. Because the distal sheath 24is connected to the outer shaft 22 which, in turn, is connected to theinner carriage 40 and thus fixed relative to the frame 30, and becausethe distal tip 14 is connected to the inner shaft 26, sliding the innershaft proximally relative to the frame will slide the distal tipproximally relative to the distal sheath, which may continue until thedistal tip contacts the distal end 27 of the distal sheath and thecompartment 23 is completely covered.

Once the valve has been properly positioned relative to the aorticannulus, the user may complete the deployment process. To do so, theuser slides the control member 50 of the resheathing lock from thelocked position to the unlocked position, thereby retracting the pin 51so that the carriage assembly 40 is free to continue its movementproximally beyond the stop member 52. The user can continue to slide thecarriage assembly 40 proximally to complete the deployment of the valveby rotating the deployment actuator 21 or by squeezing the lockingmembers 80 inwardly towards one another while grasping the coupler 60and pulling same proximally within the frame 30. When the valve isunsheathed, the stent portion of the valve self-expands and isdisengaged from the retainer 25, thereby releasing the valve from thecatheter assembly 16.

Referring now to FIG. 4, an exemplary transapical delivery device 110for a collapsible prosthetic heart valve (or other types ofself-expanding collapsible stents) has a catheter assembly 116 fordelivering the heart valve to and deploying the heart valve at a targetlocation, and an operating handle 120 for controlling deployment of thevalve from the catheter assembly. The delivery device 110 extends from aproximal end 112 to a distal tip 114. The catheter assembly 116 isadapted to receive a collapsible prosthetic heart valve (not shown) in acompartment 123 defined around a tubular support shaft 121 and coveredby a distal sheath 124.

The support shaft 121 extends between a pair of spaced retainers 125 and127 affixed thereto and defining the ends of the compartment 123. Acollapsible prosthetic valve may be assembled around the support shaft121 and between the retainers 125 and 127 in the compartment 123.

The distal sheath 124 surrounds the support shaft 121 and is slidablerelative to the support shaft such that it can selectively cover oruncover the compartment 123. The distal sheath 124 is affixed at itsdistal end to the distal tip 114, and its proximal end 129 abuts theretainer 127 when the distal sheath is fully covering the compartment123, as shown in FIG. 4. The proximal end 129 of the distal sheath 124is spaced apart from the retainer 127 when the compartment 123 is atleast partially uncovered.

The delivery device further includes an outer shaft 122, the proximalend of which is connected to the operating handle 120, and the distalend of which is connected to the retainer 127. An inner shaft 126extends through the operating handle 120 and the support shaft 121 tothe distal tip 114. The connection of the distal sheath 124 to thedistal tip 114 thus enables the inner shaft 126 to control the movementof the distal sheath both proximally and distally.

The operating handle 120 is adapted to control deployment of aprosthetic valve located in the compartment 123 by permitting a user toselectively slide the inner shaft 126 and the attached distal sheath 124distally or proximally relative to the support shaft 121, therebyrespectively uncovering or covering the compartment with the distalsheath. The proximal end of the outer shaft 122 is connected to an outerframe 130 of the operating handle 120, and the proximal end of the innershaft 126 is connected to a carriage assembly 140 of the operatinghandle that is slidable along a longitudinal axis of the frame (althoughthe longitudinal position of the inner shaft relative to the carriageassembly can be adjusted, as described below), such that a user canselectively slide the inner shaft relative to the outer shaft by slidingthe carriage assembly relative to the frame. A hemostasis valve 128provides an internal gasket adapted to create a seal between the innershaft 126 and the proximal end of the outer shaft 122. The strength ofthis seal may be adjusted by a gasket adjustment wheel 142 thatfunctions in substantially the same manner as the adjustment wheel 42described above.

The frame 130 includes a pair of side rails 131 joined at the proximalend 112 by an end member 132 and joined at the distal end by an endmember 133. Collectively, the side rails 131, the end member 132, andthe end member 133 define an elongated space 134 in the frame 130 inwhich the carriage assembly 140 may travel. An enlarged bore 135 in theproximal end member 132 is sized to freely and slidingly receive athreaded rod (not shown in FIG. 4) extending from the proximal end ofthe carriage assembly 140, as described below. The carriage assembly 140includes a main body 141 and the threaded rod extending proximallytherefrom along the longitudinal axis of the frame 130.

A coupler 160 may be configured in much the same manner as the coupler60 described above with reference to FIGS. 1 and 2, and the lockingmembers 180 included in the coupler 160 may have the same structure andfunction as the locking members 80 described above. That is, the lockingmembers 180 may each include a pin (not shown) that cooperates with thenotches 137 formed on an inner surface 139 of each side rail 131 to lockthe coupler 160 in a fixed longitudinal position relative to the frame130. However, the coupler 160 is slidably engaged with the side rails131 proximally of the carriage assembly 140 and distally of the proximalend member 132. A deployment actuator 121 located within a pocket 172 inthe coupler 160 is threadedly engaged with the threaded rod extendingfrom the carriage assembly 140. Rotation of the deployment actuator 121in one direction (either clockwise or counterclockwise depending on theorientation of the threads on the threaded rod of the carriage assembly140) causes the threaded rod to move proximally within a central bore171 of the coupler 160, at the same time pulling the carriage assembly140 proximally toward the proximal end member 132. Similarly, rotationof the deployment actuator 121 in the opposite direction causes thethreaded rod of the carriage assembly 140 to move distally within thecentral bore 171, at the same time pushing the carriage assemblydistally through the elongated space 134.

The operating handle 120 may also include a resheathing lock mechanismfor preventing the user from accidentally completing the deployment of avalve located in the compartment 123. The resheathing lock mechanism mayinclude a resheathing lock member 155 that projects through the siderail 131 of the frame 130 and into the elongated space 134 so as toobstruct the path of travel of the carriage assembly 140 in the distaldirection. As such, the resheathing lock member 155 defines the initialdistance that the carriage assembly 140 may travel before fulldeployment of the valve occurs. The resheathing lock member 155 may bemoved to an unlocked position by retracting the lock member by asufficient amount that it no longer protrudes into the space 134. Withthe resheathing lock member 155 in the unlocked position, the carriageassembly 140 may continue to move distally, thereby allowing for fulldeployment of the valve. Optionally, the locking member 155 may bedesigned to be fully removable from the frame 130 and disposable.Alternatively, the resheathing lock mechanism shown and described withreference to FIGS. 1 and 2, or any other resheathing lock mechanismhaving an appropriate configuration, may be incorporated into theoperating handle 120 in place of the resheathing lock member 155.

The carriage assembly 140 has a longitudinal bore 192 extendingpartially therethrough and sized to freely and slidingly receive athreaded rod 194 therethrough. A pocket 193 extends vertically throughthe carriage assembly 140 for receiving a shaft adjustment nut 199 inthreaded engagement with the threaded rod 194. The pocket 193 is sizedand shaped to receive the shaft adjustment nut 199 with minimalclearance, such that the shaft adjustment nut remains substantiallyfixed relative to the frame 130 as it rotates on the threaded rod 194.Accordingly, rotation of the shaft adjustment nut 199 in one direction(either clockwise or counterclockwise depending on the orientation ofthe threads on the threaded rod 194) causes the threaded rod 194 to moveproximally within the bore 192, and rotation of the shaft adjustment nut199 in the opposite direction causes the threaded rod 194 to movedistally within the bore 192. The threaded rod 194 has an interior boreextending longitudinally therethrough, the bore being sized to receivethe proximal end of the inner shaft 126. The attachment of the innershaft 126 to the threaded rod 194 includes similar structure as theattachment of the inner shaft 26 to the threaded rod 94 described above.

The operation of the operating handle 120 to deploy a prosthetic valvefrom the compartment 123 is similar to the operation of the operatinghandle 20 described above with reference to FIGS. 1-3. The user canrotate the deployment actuator 121 to slide the carriage assembly 140distally within the elongated space 134 in the frame 130, which therebypushes the distal sheath 124 distally relative to the compartment 123and exposes and initiates deployment of the valve located therein.

After movement of the distal sheath 124 has partially revealed thecompartment 123, the user may continue the deployment process withoutuse of the deployment actuator 121 by squeezing the locking members 180inwardly towards one another to release the coupler 160, andsimultaneously pushing the coupler distally within the frame 130. As thecoupler 160 is pushed distally within the frame 130, the linking of thecoupler to the carriage assembly 140 through the threaded rod (notshown) and the deployment actuator 121 results in a concomitant distalmovement of the carriage assembly, and with it, the distal sheath 124.Similar to the deployment process described above with reference to theoperating handle 20, completing the deployment process while squeezingthe locking members 180 may allow such process to be completed morequickly.

Since the resheathing lock member 155 is in the locked position,movement of the carriage assembly 140 distally may continue only untilthe distal end of the carriage assembly contacts the lock member. Atthis juncture, the distal sheath 124 will not be fully withdrawn fromthe compartment 123, and the prosthetic valve will not be fullydeployed. Therefore, if the user desires to resheathe and reposition thevalve before full deployment, the user can do so by rotating thedeployment actuator 121 in the direction opposite that used fordeployment until the carriage assembly 140 contacts the coupler 160.

If, during deployment, the user has partially deployed and thenresheathed the valve, the outer shaft 122 and/or the inner shaft 126 mayhave become temporarily or permanently deformed, such that therespective distal ends thereof may be longitudinally displaced relativeto one another. Such permanent deformation of these components mayresult in an inability of the distal sheath 124 to completely cover thecompartment 123 such that the proximal end 129 of the distal sheath maynot extend far enough to abut the retainer 127.

To adjust the relative longitudinal positions of the retainer 127 andthe distal sheath 124, the user may rotate the shaft adjustment nut 199,causing the threaded rod 194 and the inner shaft 126 affixed thereto toslide proximally relative to the inner carriage 140. Because the distalsheath 124 is connected to the inner shaft 126 which, in turn, isconnected to the inner carriage 140 and thus fixed relative to the frame130, and because the retainer 127 is connected to the outer shaft 122which is connected to the frame 130, sliding the inner shaft proximallyrelative to the frame will slide the distal sheath proximally relativeto the retainer 127, which may continue until the proximal end 129 ofthe distal sheath contacts the retainer and the compartment 123 iscompletely covered.

Once the valve has been properly positioned, the deployment operationmay be completed by withdrawing the resheathing lock member 155 to theunlocked position and moving the carriage assembly 140 further distallyuntil the valve is fully deployed.

The operating handles described herein may be provided with a deploymentlocking mechanism. Such a deployment locking mechanism may prevent theaccidental initiation of deployment by fixing the carriage assembly tothe frame while the lock is in a locked position. Such a deployment lockmay have a structure similar to the deployment locks shown and describedin co-pending U.S. Patent Application No. 61/376,425, filed on Aug. 24,2010.

Although the operating handles have been described herein as having oneresheathing lock, any number of resheathing locks may be used, with orwithout a deployment lock, resulting in any number of stages in thedeployment process. For example, there may be two, three, four, five,six or more resheathing locks, which thus enable the deploymentprocedure to be controlled incrementally. Such multiple resheathinglocks may have a structure similar to the resheathing locks shown anddescribed in co-pending U.S. Patent Application No. 61/376,425, filed onAug. 24, 2010.

More particularly, if a user desires, for example, a two-stagedeployment process, a single resheathing lock may be used, resulting inan unsheathing of perhaps about 80% to about 90% of the valve in a firstdeployment stage, followed by an unsheathing of the remaining about 10%to about 20% of the valve in a second deployment stage.

If the user desires a three-stage deployment process, on the other hand,a single resheathing lock may be used with a deployment lock, resultingin a first deployment stage in which no deployment can occur, a seconddeployment stage in which, for example, about 80% to about 90% of thevalve is unsheathed, and a third deployment stage in which the remainingabout 10% to about 20% of the valve is unsheathed.

Still further, if the user desires a four-stage deployment process, tworesheathing locks may be used with a deployment lock, resulting in afirst deployment stage in which no deployment can occur, a seconddeployment stage in which, for example, about 50% of the valve isunsheathed, a third deployment stage in which, for example, about 80% toabout 90% of the valve is unsheathed, and a fourth deployment stage inwhich the remaining about 10% to about 20% of the valve is unsheathed.This last process may be modified to a three-stage deployment process byomitting the deployment lock while keeping the two resheathing locks.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

It will be appreciated that the various dependent claims and thefeatures set forth therein can be combined in different ways thanpresented in the initial claims. It will also be appreciated that thefeatures described in connection with individual embodiments may beshared with others of the described embodiments.

The invention claimed is:
 1. A delivery device for a collapsibleprosthetic heart valve, the delivery device comprising: an operatinghandle, including: a frame defining a movement space therein; a carriageassembly moveable in a longitudinal direction within the movement space;a coupler; and a deployment actuator constrained relative to the couplerin the longitudinal direction, the coupler having a locked condition inwhich the coupler is connected to the frame in a fixed position and inwhich rotation of the deployment actuator moves the carriage assembly inthe longitudinal direction relative to the coupler with a mechanicaladvantage, and an unlocked condition in which the coupler, thedeployment actuator, and the carriage assembly are movable together inthe longitudinal direction within the movement space without amechanical advantage, the coupler being operatively connected to thecarriage assembly for movement therewith, the coupler being selectivelylockable to the frame in any of a plurality of fixed positions in thelongitudinal direction; and a catheter assembly, including: a firstshaft around which a compartment is defined, the first shaft beingoperatively connected to the frame, the compartment being adapted toreceive the valve in an assembled condition; and a distal sheathoperatively connected to the carriage assembly, the distal sheath beingmoveable between a closed condition adapted to maintain the valve in theassembled condition and an open condition adapted to fully deploy thevalve, wherein movement of the carriage assembly in the longitudinaldirection in the movement space moves the distal sheath between theclosed condition and the open condition.
 2. The delivery device of claim1, wherein the coupler includes a releasable pin and the frame has aplurality of fixed notches, the pin being engageable in one of thenotches to lock the coupler to the frame.
 3. The delivery device ofclaim 1, wherein the coupler is selectively lockable to the frame inpositions that correspond to positions of the distal sheath between theclosed condition and the open condition.
 4. The delivery device of claim1, wherein the operating handle further includes a threaded rodextending from the carriage assembly through the coupler, the deploymentactuator being threadedly engaged with the threaded rod, such thatrotation of the deployment actuator moves the threaded rod in thelongitudinal direction in the movement space.
 5. The delivery device ofclaim 4, wherein rotation of the deployment actuator in a firstdirection moves the carriage assembly proximally in the longitudinaldirection in the movement space, and rotation of the deployment actuatorin a second direction opposite the first direction moves the carriageassembly distally in the longitudinal direction in the movement space.6. The delivery device of claim 1, further comprising a latch mechanismadapted to releasably fix the coupler relative to the frame at any of aplurality of longitudinal positions in the movement space.
 7. Thedelivery device of claim 1, wherein the operating handle furtherincludes a resheathing lock having a locked position and an unlockedposition, the resheathing lock in the locked position limiting movementof the carriage assembly in the longitudinal direction to a stopposition in the movement space, and the resheathing lock in the unlockedposition permitting movement of the carriage assembly beyond the stopposition, wherein movement of the carriage assembly to the stop positionmoves the distal sheath to a condition between the closed condition andthe open condition so that the valve is not fully deployed.
 8. Thedelivery device of claim 7, wherein the frame includes a slot and theresheathing lock includes a retractable pin that is engaged in the slotwhen the resheathing lock is in the locked position, and a stop memberlocated within the slot defines the stop position.
 9. The deliverydevice of claim 8, wherein the stop member is longitudinally moveablewithin the slot, such that movement of the stop member changes thelocation of the stop position relative to the frame.
 10. The deliverydevice of claim 7, wherein the compartment has a first length and thestop position in the movement space corresponds to a travel distance ofthe carriage assembly, the travel distance being less than the firstlength.
 11. The delivery device of claim 10, wherein the collapsibleprosthetic heart valve has a second length and the travel distance isbetween about 80% and about 90% of the second length.
 12. The deliverydevice of claim 1, wherein the catheter assembly further includes anouter shaft connecting the carriage assembly to the distal sheath and atleast partially surrounding the first shaft.
 13. The delivery device ofclaim 1, wherein the operating handle further includes a mechanismadapted to move the first shaft proximally relative to the frame. 14.The delivery device of claim 13, wherein the mechanism includes athreaded rod operatively connected to the first shaft and extending inthe longitudinal direction, and a nut threadedly engaged with thethreaded rod and longitudinally constrained relative to the frame. 15.The delivery device of claim 1, wherein the catheter assembly furtherincludes an inner shaft connecting the carriage assembly to the distalsheath, the first shaft at least partially surrounding the inner shaft,and an outer shaft connecting the frame to the first shaft and at leastpartially surrounding the inner shaft.
 16. The delivery device of claim15, wherein the operating handle further includes a mechanism adapted tomove the inner shaft proximally relative to the carriage assembly. 17.The delivery device of claim 16, wherein the mechanism includes athreaded rod operatively connected to the inner shaft and extending inthe longitudinal direction, and a nut threadedly engaged with thethreaded rod and longitudinally constrained relative to the carriageassembly.